Get the free meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)
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Das Dokument ist ein Meldformular für Rückrufe oder andere Sicherheitsmaßnahmen im Zusammenhang mit Medizinprodukten, das an nationale Behörden gesendet wird.
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How to fill out meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)
How to fill out meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)
01
Start by downloading the meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7) from the official website.
02
Fill in the 'Product Information' section, providing details about the medical device, including name and model.
03
Complete the 'Manufacturer Information' section, including the manufacturer's name, address, and contact details.
04
In the 'Reason for the Recall or Safety Measure' field, provide a clear and concise explanation of why the recall or safety measure is being initiated.
05
Fill out the 'Affected Units' section, detailing the specific batch or lot numbers involved in the recall.
06
Indicate any actions taken or recommended for users or patients on the form.
07
Review all the information for accuracy and completeness.
08
Submit the completed form to the relevant regulatory authority.
Who needs meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)?
01
Manufacturers of medical devices who are conducting recalls or implementing safety measures.
02
Regulatory authorities that oversee medical device compliance and safety.
03
Healthcare providers who need to inform patients or users about recalls.
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People Also Ask about
What is the difference between Meddev and Mdcg?
MEDDEV guidance documents, like 2.7/1 Rev. 4, are aligned with the old Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). MDCG guidance documents, on the other hand, are aligned with the new EU Medical Device Regulations (MDR).
What is the current revision of Meddev 2.7 1?
Revision 4 of Clinical Evaluation guidance document MEDDEV 2.7. 1 was released by the European Commission on 1 July 2016. A copy of the latest revision can be downloaded from our website.
Is MDD 93/42 EEC still valid?
Directive 93/42/EEC - applicable until 25.05. 2021, repealed by Regulation (EU) 2017/745.
Are Meddev documents still valid?
With the replacement of the EU directives MDD, AIMDD, and IVDD by the EU regulations MDR and IVDR, the MEDDEV documents are largely obsolete. One exception is, for example, the MEDDEV 2.7/1 rev 4 guideline. Manufacturers and notified bodies should, therefore, always check whether there is a suitable MDCG guideline.
What is the acronym Meddev?
MEDDEV is an acronym for MEDical DEVices Documents.
Is Meddev 2.12 1 rev 8 still valid?
MEDDEV 2.12-1 Rev 8 provides guidance to medical device manufacturers on market surveillance. It continues to be the primary guidance document for vigilance reporting, even with the implementation of the new EU MDR and IVDR.
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What is meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)?
The 'meldeformular für rückrufe oder andere sicherheitsmassnahmen' refers to a reporting form for recalls or other safety measures related to medical devices, as outlined in the regulatory guidance document MEDDEV 2.12 Rev 7.
Who is required to file meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)?
Manufacturers and authorized representatives of medical devices are required to file the 'meldeformular' when they initiate a recall or other safety measures for their products.
How to fill out meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)?
To fill out the 'meldeformular', the filer must complete various sections that include device identification, details of the recall or safety measure, potential risks, and actions taken to notify affected users, ensuring all information is accurate and comprehensive.
What is the purpose of meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)?
The purpose of the 'meldeformular' is to communicate vital information regarding recalls or safety measures to regulatory authorities, ensuring patient safety and proper management of risks associated with medical devices.
What information must be reported on meldeformular für rückrufe oder andere sicherheitsmassnahmen (meddev 2.12 rev 7)?
The information that must be reported includes details about the medical device, nature of the recall or safety measure, identification of affected batches, potential risks to health, and measures taken to mitigate those risks.
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